Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202105562059108 Date of Approval: 17/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Granulocyte-Macrophage Colony-Stimulating Factor containing medium for Recurrent Pregnancy Loss Patients.
Official scientific title The use of culture medium supplemented with Granulocyte-Macrophage Colony-Stimulating Factor for Recurrent Pregnancy Loss Patients, A pilot study on 200 cases.
Brief summary describing the background and objectives of the trial GM-CSF (Granulocyte Macrophage colony stimulating factor) is a cytokine that is secreted by the fallopian tube and uterine epithelial cells during the mid-luteal phase. It operates as a survival factor for the embryos against apoptosis that occurs in the absence of cytokines. It is thought to support pregnancy by facilitating trophoblast cell growth and shifting the maternal immune system to a state that supports fetal growth. Our objective is to study its effect when added to culture and transfer medium used for recurrent abortions cases.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 01/04/2021
Actual trial start date 01/04/2021
Anticipated date of last follow up 01/06/2023
Actual Last follow-up date 01/10/2023
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Embryo culture and transfer in GMCSF supplemented medium. GM-CSF 2ng/ml in embryo culture medium. From oocyte injection till embryo transfer. Following Intra-cytoplasmic sperm injection (ICSI), the injected oocytes will be cultured in culture medium supplemented with GM-CSF Factor till embryo transfer (fresh or after vitrification and worming for freeze all cases). 100
Control Group Embryo culture and transfer in medium not supplemented by GMCSF. No GM-CSF in embryo culture medium. From oocyte injection till embryo transfer. Following Intra-cytoplasmic sperm injection (ICSI), the injected oocytes will be cultured and transferred in culture medium not supplemented with GM-CSF Factor till embryo transfer (fresh or after vitrification and worming for freeze all cases). 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women aged 19 to 44 years and had a history recurrent miscarriage: loss of two or more consecutive pregnancies before 20 weeks. Those women should have a regular menstrual cycle of 21 to 35 days, treated per standard protocols. Women aged over 44 or had an anatomic disorder of the uterus, chromosomal defects in the couple, medical conditions or genetic disorders prohibiting IVF/ICSI or interfering with the interpretation of results. ICSI cycles requiring pre-implantation genetic diagnosis. Adult: 19 Year-44 Year 19 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/04/2021 Adam International Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Aden Giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Continued pregnancy 20 weeks of gestation
Secondary Outcome Clinical pregnancy 6 weeks after embryo transfer.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Adam fertility and sterility hospital Aden Giza 12655 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Adam International Hospital Aden Giza 12655 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adam Internntional Hospital Aden Giza 12511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emad Fakhry emadfakhrylabib@gmail.com +201287508483 Aden
City Postal code Country Position/Affiliation
Giza 12511 Egypt Adam International Hospital
Role Name Email Phone Street address
Public Enquiries Emad Fakhry emadfakhrylabib@gmail.com +201287508483 Aden
City Postal code Country Position/Affiliation
Giza 12511 Egypt Adam International Hospital
Role Name Email Phone Street address
Scientific Enquiries Emad Fakhry emadfakhrylabib@gmail.com +201287508483 Aden
City Postal code Country Position/Affiliation
Giza 12511 Egypt Adam International Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after de-identification. Study Protocol Beginning 3 months and ending 5 years following article publication. Researchers who provide a methodologically sound proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
emadfakhrylabib@gmail.com No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information